NCT02770651

Brief Summary

The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

May 1, 2016

Last Update Submit

January 22, 2018

Conditions

Coronary Artery DiseaseCoronary DiseaseMyocardial IschemiaArterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesHeart DiseasesVascular Diseases

Keywords

optical coherence tomographyeverolimus-eluting stentzotarolimus-eluting stent

Outcome Measures

Primary Outcomes (1)

  • Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups

    Incidence of malapposed and uncovered stent strut measured by OCT

    12month

Secondary Outcomes (3)

  • Percent neointima cross-sectional area

    12month

  • Mean neointima thickness

    12month

  • Morphologic characteristics of neointima

    12month

Study Arms (1)

Optical Coherence Tomography

To evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymerversus zotarolimus-eluting stent (ZES) with permanent polymer implantation in patients with AMI at 12 months.

Device: Everolimus-Eluting stentDevice: Zotarolimus-Eluting stent

Interventions

Everolimus-Eluting stentDEVICE

Everolimus-Eluting stent with bioabsorbable polymer

Also known as: Synergy™
Optical Coherence Tomography
Zotarolimus-Eluting stentDEVICE

Zotarolimus-Eluting stent with permanent polymer

Also known as: Resolute Onyx™
Optical Coherence Tomography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI

You may qualify if:

  • Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI
  • Patient ≥ 18 years of age
  • Patient judged suitable to receive anti-platelet drugs of ASA and ticagrelor for at least 12 months after the procedure
  • The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic, OCT follow up and provides informed consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
  • culprit lesion

You may not qualify if:

  • The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, abciximab, aspirin, ticagrelor, everolimus, zotarolimus, polymer, platinum chromium, cobalt chromium, contrast media
  • Female of childbearing potential unless a pregnancy test is negative or who possibly plan to become pregnant any time after enrollment
  • Cardiogenic shock
  • Patient with left ventricular ejection fraction \<30%
  • Patient with left main disease
  • Patient with In-stent restenosis (ISR) at target vessel (either bare metal stent or DES, non-target vessel ISR is permitted)
  • Patient with impaired renal function (creatinine \>2.0mg/dL)
  • Patient with inadequate OCT images quality due to severe calcification, vessel tortuosity and artifacts
  • bifucation lesion needs complex procedure with insert two or more Drug eluting stents.
  • lesion length \>30mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Related Publications (5)

  • Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, Cui JG, Mintz GS, Gao RL. Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial. EuroIntervention. 2014 Nov;10(7):806-14. doi: 10.4244/EIJY14M07_17.

    PMID: 25033105BACKGROUND

  • Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.

    PMID: 22179532BACKGROUND

  • Kim S, Kim JS, Shin DH, Kim BK, Ko YG, Choi D, Cho YK, Nam CW, Hur SH, Jang Y, Hong MK. Comparison of early strut coverage between zotarolimus- and everolimus-eluting stents using optical coherence tomography. Am J Cardiol. 2013 Jan 1;111(1):1-5. doi: 10.1016/j.amjcard.2012.08.037. Epub 2012 Oct 2.

    PMID: 23040589BACKGROUND

  • Karjalainen PP, Varho V, Nammas W, Mikkelsson J, Pietila M, Ylitalo A, Airaksinen JK, Sia J, Nyman K, Biancari F, Kiviniemi T. Early neointimal coverage and vasodilator response following biodegradable polymer sirolimus-eluting vs. durable polymer zotarolimus-eluting stents in patients with acute coronary syndrome -HATTRICK-OCT trial. Circ J. 2015;79(2):360-7. doi: 10.1253/circj.CJ-14-1000. Epub 2014 Dec 15.

    PMID: 25502167BACKGROUND

  • Lee CH, Lee S, Hwang J, Kim IC, Cho YK, Yoon HJ, Kim H, Nam CW, Hur SH. Late stent strut apposition and coverage after drug-eluting stent implantation by optical coherence tomography in patients with acute myocardial infarction. Coron Artery Dis. 2025 Nov 1;36(7):610-617. doi: 10.1097/MCA.0000000000001536. Epub 2025 Sep 24.

    PMID: 40421609DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseMyocardial IschemiaArterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesHeart DiseasesVascular Diseases

Study Officials

  • Seung-Ho Hur, Postdoctoral

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

May 1, 2016

First Posted

May 12, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

KR(1)